This interactive course provides an advanced, practical detailed interactive review of the organizational fundamentals of Good Clinical Practice (GCP). Participants will acquire real-world application of GCP regulations and guidelines for critical elements of the clinical research and development process. This training includes the updates brought by the ICH E6 R2 Addendum.
During this interactive workshop, we will debate in what way clinical research team members can apply systems to achieve data integrity and quality through the trial lifecycle.
Specific attention will be given to how quality systems affect overall data integrity, patient clinical risk, and respective regulatory risk.
- Describe the elements of functional Quality Systems for Sponsors, Institutional Review Boards (IRBs), and Clinical Investigators
- Identify the universal and local components of GCP
- Explain the differences between the legal and procedural elements of GCP
- Describe the overlap between GCP and Good Manufacturing Practice (GMP)
- Recognize key differences in pharmaceutical, device, and biologics GCP
- Examine recent trends in non-compliance
- Develop and implement site-specific approaches for corrective action of non-compliance
- Principles of GCP: Different Perspectives: Examination; application; implementation
- New Developments and Emerging Trends in GCP
- The “Forgotten” Elements of GCP: Regulations; laws; guidelines
- Quality Systems: The Roadmap to GCP: Quality control; quality assurance; quality improvement
- Quality Risk Management (QRM) in Clinical Trials: Application of risk assessment in the review of protocols
- The Role of Standard Operating Procedures in GCP: Rationale; development; training; implementation; maintenance
- GCP Across Investigational Products: Drugs; devices; biologics
- Are We There Yet? Recent non-compliance issues with discussion of Corrective and Preventive Action planning
Who will Benefit:
This program is designed for professionals with two to three years of experience in the clinical research industry. Clinical Research Associates, Project Managers, Investigators, Study Coordinators, and GCP Focused Regulatory Affairs Professionals.